Scientist

Description

On-Site is strongly preferred.

It is more documentation, regulatory coordination, tracking, and project support.

Strong communication skills, this person will be expected to reach out both within our department and cross functionally to ensure timely input to regulatory responses

What does a typical day look like? (daily tasks) Tracking of activities and deliverables

• Documentation search and review
• Regulatory Response preparation and review
• Knowledge gathering and organization

Preferred background/prior work experience? IVD molecular diagnostic Assay Product Development

Reports to: R&D Assay Development On-Market Support Team Lead

Position Summary:

We are seeking a motivated and detail-oriented Scientist II (Senior Scientist equivalent) for a one-year temporary assignment within our R&D Assay Development On-Market Support team.

• This role is dedicated to supporting global regulatory submissions for our on-market products.
• The successful candidate will be responsible for project management, regulatory response coordination, and documentation strategy, contributing directly to the continued success of our product portfolio.

Key Responsibilities:

Regulatory Submission Support:

• Coordinate and deliver timely, informed responses to global regulatory authorities’ questions related to assay development and product performance.
• Collaborate cross-functionally with Regulatory Affairs, Quality, and R&D teams to gather and synthesize necessary information for submissions.

Project Management:

• Track and manage activities and deadlines related to regulatory submissions and post-market support projects.
• Maintain project timelines and communicate status updates to stakeholders.

Product Knowledge Repository:

• Establish and maintain a comprehensive repository of product knowledge, including technical documentation, study data, protocols, and regulatory correspondence.
• Ensure the repository is organized, accessible, and up-to-date for internal use.

Documentation Strategy:

• Assess current documentation and design history files for completeness and regulatory readiness.
• Make recommendations and develop strategic plans to address gaps, including proposing new study plans, protocols, and documentation updates.
• Partner with subject matter experts to drive documentation improvements and ensure compliance with global regulatory requirements.

Qualifications:

• PhD or MS in life sciences, chemistry, biochemistry, or related field (or equivalent experience).
• 3+ years of experience in assay development, R&D, or related scientific role; experience in regulated environments preferred.
• Demonstrated experience supporting global regulatory submissions or working with regulatory authorities.
• Experience with documentation systems, design history files, and regulatory documentation standards.
• Proficiency in Microsoft Office and project management tools.

Preferred Qualifications:

• Previous experience in on-market support for medical devices, diagnostics, or related regulated products.
• Familiarity with global regulatory requirements (e.g., FDA, CE, PMDA).
• Experience in establishing knowledge repositories or databases.